DA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration and testing process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential danger or injury if administered.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Singapore has released an update to healthcare professionals on two recent pharmacoepidemiological studies using data from Danish registries which suggested a cumulative dose-dependent association between the prolonged use of hydrochlorothiazide­containing medicines and Non-melanoma skin cancer (NMSC).

Scientific Discussion

Hydrochlorothiazide (HCTZ) is used alone or together with other medicines to treat high blood pressure (hypertension). It is also used to treat fluid retention (edema) that is caused by congestive heart failure, severe liver disease (cirrhosis), kidney disease, or treatment with a steroid or hormone medicine.

Skin cancer is one of the most common cancers worldwide. It used to be more common among caucasians, but with the depletion of the ozone layer, ultraviolet rays from the sun are now capable of causing skin cancer. Other factors that cause skin cancer include: exposure to coal, arsenic, genetics, and pre-existing skin conditions, immunosuppression and photosensitizing medications. Skin cancer has two major types: Melanoma and Non-melanoma skin cancer (NMSC). NMSC has two subtypes: Basal Cell Carcinoma (BCC) and Squamous Cell Carcinoma (SCC). Both are commonly seen on older generation because 80% of these tumors is caused by cumulative sun exposure.

There are about 302 HCTZ prescription drugs that have been registered in the Philippines, either as single ingredient or fixed-dose combinations. To date, FDA Philippines has not received any adverse drug reactions reports of Non-melanoma skin cancer with prolonged use of HCTZ.

Safety Advisory

Healthcare professionals should inform their patients on the risk of NMSC and should advise them to regularly check their skin for new marks or growths and any changes to existing marks. Alternatives to HCTZ may be considered for patients who are at high risk for NMSC such as known personal or family history of skin cancer, ongoing immunosuppressive therapy and light colored skin. Possible preventive measures such as limited exposure to sunlight and UV rays and, in case of exposure, adequate protection should be advised to the patients in order to minimize the risk of skin cancer. Suspicious skin lesions should be promptly examined potentially including histological examinations of biopsies.

Healthcare professionals are also encouraged to report any serious adverse reactions, including Non-melanoma skin cancer, related to HCTZ-containing products, to the FDA.

Information for Market Authorization Holders

The Market Authorization Holders of HCTZ-containing products shall update their respective package inserts to reflect the information on risk of Non-melanoma skin cancer. This information should appear under Special Warnings and Precautions. MAHs are hereby directed to submit their revised package inserts in relation to the above safety concern by filing variation application within 3 months after this issuance.

Provided below is the suggested text for the revised package insert:

An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide (HCTZ) exposure has been observed in two epidemiological studies based on the Danish National Cancer Registry. Photosensitizing actions of HCTZ could act as a possible mechanism for NMSC.

Patients taking HCTZ should be informed of the risk of NMSC and advised to regularly check their skin for any new lesions and promptly report any suspicious skin lesions. Possible preventive measures such as limited exposure to sunlight and UV rays and, in case of exposure, adequate protection should be advised to the patients in order to minimize the risk of skin cancer. Suspicious skin lesions should be promptly examined potentially including histological examinations of biopsies. The use of HCTZ may also need to be reconsidered in patients who have experienced previous NMSC.

In compliance with Republic Act No. 10354, also known as “The Responsible Parenthood and Reproductive Health Act of 2012” and its IRR, the Food and Drug Administration (FDA) hereby invites all concerned to submit their petitions and any corresponding evidence on the mechanism of action of the following contraceptive products within ten (10) calendar days from the posting of this Advisory:

Documents and scientific evidence can be submitted to the Food and Drug Action Center (FDAC), 3™ Floor Starmall, Alabang, Muntinlupa on Mondays to Fridays, 8:00 am to 5:00 pm.

August 29, 2019 / In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-256 || Certification of Contraceptive Products in Compliance to the Implementing Rules and Regulations of the Republic Act No. 10354, Also Known as the Responsible Parenthood and Reproductive Health Act of 2012

The Food and Drug Administration (FDA) warns the public against the purchase and use of five other versions of counterfeit VERORAB RABIES VACCINE FOR HUMAN USE, PREPARED ON CELL CULTURES (INACTIVATED).

The FDA, together with the Marketing Authorization Holder (MAH), Sanofi Pausteur Inc., have verified that the aforementioned products in Figures 1, 2, 3, 4, 5 & 8 are counterfeit.

The Lot numbers that were confirmed by the Marketing Authorization Holder (MAH), Sanofi Pasteur Inc. as counterfeit versions are the following. Moreover, no Lot Release Certificates were issued by FDA on these product lots:

July 15, 2019 / In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-190 || Public Health Warning Against the Purchase and Use of Five Other Versions of Counterfeit VERORAB RABIES VACCINE FOR HUMAN USE, PREPARED ON CELL CULTURES (INACTIVATED)

The Food and Drug Administration (FDA) warns the public from purchasing and using the following unregistered drug product:

HYSSOP Mineral Drops 15 mL

The FDA has verified through post-marketing surveillance that the abovementioned drug product is not registered and the Certificate of Product Registration (CPR) has not been issued. Pursuant to the Republic Act No. 9711, otherwise known as “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health product without the proper authorization is prohibited.

Since this unregistered drug product has not gone through evaluation process of the FDA, the agency cannot assure its efficacy, quality and safety. The use of this violative product may pose health risk to consumers.

In light of the foregoing, the public is advised not to purchase this violative product. Moreover, the public is advised to always check if a dug product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute the violative drug product until it has been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the drug product.

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrict entry of this unregistered product.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

July 11, 2019 / In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-189 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product: HYSSOP Mineral Drops 15 mL

The Food and Drug Administration (FDA) advises the public against the purchase and use of the verified counterfeit version of drug product Co-Amoxiclav (Augmentin) Powder for Oral Suspension.

The FDA, together with the Marketing Authorization Holder (MAH), GlaxoSmithKline (GSK) Philippines, Inc., have verified that the above mentioned product is counterfeit.(please see attached photo for further details).

The Batch No. 217883A having the expiry date Dec. 2020 was not imported by GSK.

Authentic

Counterfeit

Brand name:

AUGMENTIN

AUGMENTIN 457

Container:

Colorless Glass bottle

Plastic bottle

Dosage strength & dosage form reflected on label:

457mg/5mL Powder for Suspension

400mg/5mL for Oral Suspension

Pack sizes:

35mL and 70mL

100mL

Logo:

New GSK Logo

Old GSK logo

All healthcare professionals, local health centers, health institutions and the general public are hereby warned of this counterfeit drug product in the market which pose potential danger or injury to consumers. Consumers, distributors and retailers are also reminded to purchase drug products only from FDA-licensed establishments.

Likewise, all establishments and outlets are hereby warned against selling and/or dispensing this verified counterfeit drug product with the foregoing features. The importation, selling or offering for sale, brokering, donating or possession without proof of legitimate purchase of such is in direct violation of Republic Act No. 9711, or the Food and Drug Administration Act of 2009, and Republic Act No. 8203, or the Special Law on Counterfeit Drugs, therefore a penalty shall be imposed.

The Bureau of Customs is urged to restrain the importation or entry of this counterfeit product.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that this counterfeit product is not sold, made available or used in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered or counterfeit health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

July 5, 2019 / In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-151-A || Amending FDA Advisory No. 2019-151: Public Health Warning Against the Purchase and Use of the Verified Counterfeit Version of Drug Product Co-Amoxiclav (Augmentin) Powder for Oral Suspension

The Batch numbers that were counterfeited as confirmed by the Marketing Authorization Holder (MAH), GlaxoSmithKline Philippines, Inc. are the following:

Batch no. 3503 (Figure 1)

Batch no. 3479 (Figure 2)

All healthcare professionals, local health centers, health institutions and the general public are hereby warned of these counterfeit versions which pose potential danger or injury to consumers. Consumers, distributors and retailers are also reminded to purchase drug products only from FDA-licensed establishments.

Likewise, all establishments and outlets are hereby warned against selling and/or dispensing these verified counterfeit drug products with the foregoing features. The importation, selling or offering for sale, brokering, donating or possession without proof of legitimate purchase of such is in direct violation of Republic Act No. 9711, or the Food and Drug Administration Act of 2009, and Republic Act No. 8203, or the Special Law on Counterfeit Drugs, therefore a penalty shall be imposed.

The Bureau of Customs is urged to restrict the entry of these counterfeit versions of Rabipur PCEC rabies vaccine for human use.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these counterfeit versions are not sold, made available or used in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)809-5596 or e-mail [email protected]. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

July 4, 2019 / In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-170 || Public Health Warning Against the Purchase and Use of the Counterfeit Versions of Rabipur PCEC rabies vaccine for human use

The US FDA has released safety announcement on rare occurrences of a serious infection of the genitals with sodium-glucose cotransporter-2 (SGLT2) inhibitors. The serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fourneir’s gangrene.

Scientific Discussion

SGLT2 inhibitors are approved for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. They lower plasma glucose concentrations by increasing renal excretion of glucose.

Three SGLT2 inhibitors have been registered in the Philippines since 2014, either as single ingredient or fixed-dose combinations. These are:

SGLT2 inhibitors

Brand

Market Authorization Holders

Canagliflozin

Invokana

Johnson & Johnson (Phils.) Inc.

Dapagliflozin

Forxiga

AstraZeneca Pharmaceuticals (Phils.), Inc.

Dapagliflozin + Metformin

Xigduo XR

AstraZeneca Pharmaceuticals (Phils.), Inc.

Dapagliflozin + Saxagliptin

Qtern

AstraZeneca Pharmaceuticals (Phils.), Inc.

Empagliflozin

Jardiance

Boehringer Ingelheim (Philippines), Inc.

Empagliflozin + Metformin

Jardiance Duo

Boehringer Ingelheim (Philippines), Inc.

Empagliflozin + Linagliptin

Glyxambi

Boehringer Ingelheim (Philippines), Inc.

Fournier’s gangrene is an extremely rare but life-threatening bacterial infection of the tissue under the skin that surrounds muscles, nerves, fat, and blood vessels of the perineum. Men are more often affected than women. Identified predisposing factors include diabetes mellitus, obesity, and other conditions leading to immunosuppression.

To date, FDA Philippines has not received any adverse drug reactions reports of fournier’s gangrene with SGLT2 inhibitors.

Safety Advisory

Healthcare professionals are advised to assess patients for Fournier’s gangrene if they present symptoms of pain, tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, consider discontinuation of SGLT2 inhibitor, provide appropriate alternative therapy for glycemic control and start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary.

Advise all patients to seek medical attention immediately if they experience any symptoms above.

Healthcare professionals are also encouraged to report any serious adverse reactions, including Fournier’s gangrene, related to SGLT2 inhibitors to the FDA.

Information for Market Authorization Holders

The Market Authorization Holders of SGLT2 inhibitors as listed above shall update their respective package inserts to appear the information on risk of necrotizing fasciitis of the perineum (Fournier’s gangrene). This information shall be discussed under Warnings and Precautions. MAHs who have not yet submitted their revised package inserts in relation to the above safety concern shall submit variation application within 3 months after this issuance.

The Food and Drug Administration (FDA) warns the public from purchasing and using the following unregistered drug product:

Juicy Pop! Skin Injection Serum

The FDA has verified through post-marketing surveillance that the abovementioned drug product is not registered and no Certificate of Product Registration (CPR) has been issued. Pursuant to the Republic Act No. 9711, otherwise known as “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health product without the proper authorization is prohibited.

Since this unregistered drug product has not gone through evaluation process of the FDA, the agency cannot assure its efficacy, quality and safety. The use of this violative product may pose health risks to consumers.

In light of the foregoing, the public is advised not to purchase this violative product. Moreover, the public is advised to always check if a dug product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute the violative drug product until it has been issued the appropriate authorization, a License to Operate (LTO) for the establishment and a CPR for the drug product.

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrict the entry of this unregistered product.

For more information kindly contact the FDA Center for Drug Regulation and Research through e-mail at [email protected], or call (02) 809-5596.

To report any sale or distribution of unregistered drug product, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

July 1, 2019 / In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-167 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product: Juicy Pop! Skin Injection Serum

The Food and Drug Administration (FDA) warns the public from purchasing and using the following unregistered drug products:

Lady Guada SALICYLIC ACID 25 mL

Lady Guada TINCTURE OF BENZAL 15 mL

Lady Guada OIL OF WINTER GREEN 25 mL

Lady Guada Aceite De Manzanilla 30 mL

Lady Guada EUCALYPTUS OIL 10 mL

Lady Guada HYDROGEN PEROXIDE AGUA OXIGENADA SOLUTION USP XIV

The FDA has verified through Post-Marketing Surveillance that the abovementioned drug products are not registered and no Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered drug products have not gone through evaluation process of the FDA, the agency cannot assure their efficacy, quality and safety. The use of such violative products may pose health risks to consumers.

In light of the foregoing, the public is advised not to purchase these violative products. Moreover, the public is advised to always check if a drug product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute the violative drug products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment and a CPR for the drug product.

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

For more information kindly contact the FDA Center for Drug Regulation and Research through e-mail at [email protected], or call (02) 809-5596.

To report any sale or distribution of unregistered drug product, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

The FDA has verified through post-marketing surveillance that the abovementioned drug products are not registered and no Certificates of Product Registration (CPR) have been issued. Pursuant to the Republic Act No. 9711, otherwise known as “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of these health products without the proper authorization is prohibited.

Since these unregistered drug products have not gone through evaluation process of the FDA, the agency cannot assure their efficacy, quality and safety. The use of such violative products may pose health risks to consumers.

In light of the foregoing, the public is advised not to purchase these violative products. Moreover, the public is advised to always check if a dug product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute the violative drug products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment and a CPR for the drug product.

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

For more information kindly contact the FDA Center for Drug Regulation and Research through e-mail at [email protected], or call (02) 809-5596.

To report any sale or distribution of unregistered drug product, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

“Did you know that medicines affect your baby and children in different ways? Make sure you’re giving your baby or child the right medicine in the right dose, using the right spoon, syringe or device.”

June 11, 2019 / In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-153 || Public Health Warning Against the Purchase and Use of the Verified Counterfeit Version of Drug Speeda Rabies Vaccine

June 11, 2019 / In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-152 || Public Health Warning Against the Purchase and Use of the Verified Counterfeit Version of ANTI-RABIES SERUM (EQUINE) EQUIRAB 5mL Vial

The Food and Drug Administration (FDA) warns the public on significant risks associated with the growth of the internet’ sales of medicines.

Unlike other consumer products purchased over the internet, medicines have the potential to cause serious side effects and health problems if not used and stored properly. It is important to seek medical advice from doctor or pharmacist before taking medicines.

Buying medicines over the internet can pose serious health risk. You will never know what exactly you are getting. Even if the medicines bought online looks the same; there is no guarantee that it is genuine. A medicine bought online may contain no active ingredient; too much or too little of active ingredients which may result to your condition not being treated correctly. Also, these medicines may not be stored correctly in accordance with its appropriate storage conditions.

In the Philippines, online selling of medicines is NOT permitted pursuant to existing laws, rules and regulations. Currently, FDA only allows online ordering services provided that the seller has an existing FDA-licensed Pharmacy or Botika with physical address. Online ordering services are additional activities of a Pharmacy or Botika subject for approval of FDA.

The FDA recommends purchase of medicines from licensed pharmacies near you and seek advice from your community pharmacist on the proper and safe use of medicines.

To report continuous unauthorized sale or distribution of drug products, kindly email us via [email protected], or through the online reporting facility, eREPORT, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02) 809-5596.

Quick Links

Transparency Seal

A Transparency Seal, prominently displayed on the main page of the website of a particular government agency, is a certificate that it has complied with the requirements of Section 93. This Seal links to a page within the agency’s website which contains an index of downloadable items of each of the above-mentioned documents.